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Creatine Reagent Kit Beckman Synchron CX® & CX® Delta

1. 30 18 25 37 C Diamond Diagnostics
2. Diamond Diagnostics Sodium Citrate 3 5 mg mL Ammonium Heparin 45 Units mL Sodium Heparin 45 Units mL EDTA 4 0 mg mL Lithium Heparin 45 Units mL Lithium lodoacetate 1 5 mg mL Sodium Citrate gt 3 2 3 He Diamond D
3. Precisi n Controles sera y de Orina disponibles comercialmente fueron ensayados usando ambos reactivos de Creatina de Diamond y de Beckman en el Sistema Synchron CX Delta Se corrieron las muestras por 20 d as 2 pruebas por d a 2 observaciones por cada prueba Ver la Tabla 2 mas abajo 1 2 Range of Overall Mean within Total Range of Conc Matrix Expected mg dL Reagent Ban ela N mg dL run sd sd Diamond EZ TEE ae y Serum control 1 80 1 6 0 07 0 14 Serum 9 04 0 20 mg dL Beckman 934 1143 1042 Serum Control 2 80 6 9 0 10 0 62 A 4 L Diamond 87 102 1 96 Urine Control 1 80 89 0 7 10 9 Urine 400 10mg dl Beckman 83 1029 96 2 Urine Control 2 80 217 2 2 9 5 Referencias Literarias 1 Jaffe M Z Physiological Chemistry 10 391 1886 2 Tietz N W ed Clinical Guide to Laboratory Tests 2 Edition W B Saunders Company Philadelphia 1994 3 Henry John Bernard Clinical Diagnosis and Management by Laboratory Methods 20 Edition W B Saunders Company Philadelphia 2001 4 SYNCHRON CX 3 Delta Clinical System Operating Instructions Beckman Instruments Inc Brea CA SYNCHRON CX 3 Clinical System Operating Instructions Beckman Instruments Inc Brea CA The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for
4. 1 2 Range of Overall Mean within Total Matrix e a Reagent average Mean N mg dL run sd sd Diamond Be ei Serum Control 1 80 1 6 0 07 0 14 Serum 9 04 0 20 mg dL Beckman 934 1143 104 2 Serum Control 2 80 6 9 0 10 0 62 n N Diamond 87 1021 96 Urine Control 1 80 89 0 7 10 9 zu Beckman 83 1029 96 2 Urine Control2 80 217 2 2 9 5 _Letteratura di Referenze Z 1 Jaffe M Z Chimica Fisilogica 10 391 1886 2 Tietz N W ed Guida Clinica per Test da Laboratorio 2 Edition W B Saunders Company Philadelphia 1994 3 Henry John Bernard Diagnosi Cliniche e Gestione di Metodi di Laboratorio 20 Edition W B Saunders Company Philadelphia 2001 4 SYNCHRON CX 3 Delta Istruzioni Operative per l uso del Sistema Clinico Beckman Instruments Inc Brea CA SYNCHRON CX 3 Istruzioni Operative per l uso del Sistema Clinico Beckman Instruments Inc Brea CA The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 14 of 20 DIAMOND Reagente de Creatina Beckman Synchron CX amp CX Delta Analisadores BK 443340D Portuguese Diamond Diagnostics 333 Fi
5. Diamond Creatinine Reagents Synchron Delta System Ha 20 2 2 2 1 2 N mg dL sd sd mg dL a a 1 80 1 6 0 07 0 14 E 9 04 0 20 Diamond 857 1053 98 5 2 80 6 9 0 10 0 62 mg dL Beckman 93 4 114 3 104 2 KoHT YpuHa 1 80 89 0 7 10 9 z 400 10 Diamond 87 102 1 96 YpuHa 2 80 217 2 2 9 5 mg dL Beckman 83 102 9 96 2 1 Jaffe M Z Physiological Chemistry 10 391 1886 2 Tietz N W ed Clinical Guide to Laboratory Tests 2 Edition W B Saunders Company Philadelphia 1994 3 Henry John Bernard Clinical Diagnosis and Management by Laboratory Methods 20 Edition W B Saunders Company Philadelphia 2001 4 SYNCHRON CX 3 Delta Clinical System Operating Instructions Beckman Instruments Inc Brea CA SYNCHRON CX 3 Clinical System Operating Instructions Beckman Instruments Inc Brea CA The names of various manufacturers their instruments and their products referred to herein
6. 10 to 400 mg dl OT 0 9 mg dL 1 3 1 5 1 11 and a O mg dL 5 CV 20 0 9 mg dL BUN 0 6 mg dL with Diamond 0 8 mg dL with Beckman reagent
7. Creatinine Picrate Complex red 520 nm 560 nm 25 6 B Creatine Reagent Kit BK 443340D 3 x 1600mL of 0 188 mol L NaOH sodium borate sodium phosphate x 400 mL 0 05 M in vitro
8. 0 6 to 1 2 mg dL 0 8 to 2g 24hrs Ha Delta CXO9ALX Systems Diamond Creatinine Reagent Reagent Diamond Creatinine Reagent Creatinine Reagent Diamond 0 988 Beckman 0 634 mg dL 0 999 n 45 range 10 to 400 mg dL Sy 3 17 mg dL Diamond 100 Diamond 1
9. Kyselina pikrov Kreatinine pikr t komplex erven Absorbance se m p i dvou vlnov ch d lk ch 520 nm a 560 nm a to 25 6 vte in po nast knut vzorku Rozd l absorbance je p mo m rn koncentraci kreatininu ve vzorku Reagenty Reagen n sada pro stanoven Kreatinu BK 443340D Obsahuje Alkalick pufr 3 x 1600mL je vodn roztok obsahuj c 0 188 mol L NaOH pufry s bor tem sodn m a fosf tem sodn m surfaktant a konzervant Roztok kyseliny pikrov 3 x 400 mL obsahuje 0 05 M kyseliny pikrov Pouze pro in vitro diagnostick pou it Prevence Dodr ujte z kladn laboratorn bezpe nost Pokud se produkt dostane do kontaktu s k opl chn te posti en m sto vodou Pokud se produkt dostane do o okam it vypl chn te velk m proudem tekouc vody nebo borovou vodou V p pad n hodn ho po it okam it kontaktujte l ka e P i pr ci s kyselinou pikrovou a jej m roztokem je doporu eno pou vat laboratorn pl a rukavice jeliko kyselina pikrov barv k i a oble en Skladov n 8 Doba pou it Alkalick pufr a roztok kyseliny pikrov jsou stabiln do data spot eby uveden ho na l hvi Nepou vejte produkt po uplynut t to doby Pracovn reagent skladujte ve vertik ln poloze p i teplot okoln ho prost ed mezi 18 25 C a spot ebujte do jednoho m s ce po jeho sm ch n Roztok ani pracovn reagent nezmrazujte a neuchov vejte v l
10. campioni da scegliere campione di sangue interi non sono raccomandati4 5 Anticoagulativi Compatibili o Additivi Chimici con questo metodo sono Anticoagulants Accettabile Livello Anticoagulants Accettabile Livello Anticoagulants Accettabile Livello Sodium Citrate 3 5 mg mL Ammonium Heparin 45 Units mL Sodium Heparin 45 Units mL EDTA 4 0 mg mL Lithium Heparin 45 Units mL Lithium lodoacetate 1 5 mg mL campioni collezionati in una tubazione che contiene Liquido Sodio Citrate esibir un decremento di valore all effetto diluitivo Lipemic campioni gt 3 potrebbe essere ultracentrifugato e le analisi performate sul supernatant Referimento alla Letteratura Referenze 2 e 3 e per alter interferenze causate da droghe e malattie Se la calibrazione o il controllo dello strumento difettoso e non misura entro il valore accettabile mentre utilizza il prodotto del Diamond Diagnostics Diamond Diagnostics suggerisce di fare i seguenti passi Assicurarsi che i reagenti e i calibratori interni che standardizzano lo strumento siano adeguati entro la data di scadenza e non contengono contaminazioni evidentemente visibili Seguire le procedure della Manuale del Cliente nel capitolo Correttivo Troubleshooting Assicurarsi che tutto sia appropriato con le Procedure della Manutenzione come scritto nella Manuale del Cliente Se il problema ancora esistesse contattare Il Dipartimento Servizio Tecnico del Diamond Diagnostics
11. Interval util Intervalul util pentru creatinin a fost determinat la 0 6 25 mg dL n ser sau plasm 10 400 mg dL in urina Mostrele cu concentra ie mai mare dec t intervalul util trebuie diluate cu ap deionizat sau ser fiziologic i trebuie analizate nc o dat Sensibilitate Functionala Evaluat pe diferite dilutii f cute din ser cu o concentra ie de aproximativ 0 9 mg dL dilutiile au fost f cute cu rela ie de 1 3 1 5 1 11 i una cu concentra ie O mg dL Mostrele diluate n total 4 au fost testate peste 5 cicluri calibrate Valoarea cea mai mic a coeficientei de varia ie lt 20 a fost determinat la dilutia cu valoarea a teptat de 0 9 mg dL creatin iar valoare m surat este 0 6 mg dL cu solu ie Diamond 0 8 mg dL cu solu ie Beckman Interval de Referent 5 Valorile indicate n intervale de referin sunt denumite numai ca un ghid si nu ca valori absolute Nu au fost luate n considerare v rsta sexul sau diferen e dietetice Fiecare laborator ar trebui s stabileasc un interval de referin pe baza de pacien i Tipul mostrei Unitatea SI Ser sau Plasm 0 6 1 2 mg dL Urin 0 8 2g 24hrs Caracteristici de performan Datele de performan au fost colectate pe analizori CX 3 Delta i CXO9ALX Metod de comparare Solu ia Creatin Diamond a fost comparat cu solu ie Beckman folosind mostre de ser dliuate i au fost examinate de 3 ori cu am ndou solu ie
12. Les valeurs donn es pour les intervalles de references ne sont qu indicatives et pas de valeurs absolues Pas de compte avec les facteurs d age sexe ou maladies Chaque laboratoire doit tablir ses propres intervalles de r f rence en se basant sur la population de patients Type d chantillon SI Unit Serum ou Plasma 0 6 1 2 mg dL Urine de 24 heures 0 8 2g 24hrs Performance Caract ristiques Les donn es de performance ont t collect es sur CX 3 Delta et CX 9ALX Systemes Comparaison de m thode Diamond Cr atinine Reactif a t compar avec Beckman R actif en utilsant les chantillons de serum troubles ou dilu es Test a t fait pour chague r actif Diamond Cr atinine Reactif et Beckman Cr atinine Reactif par triple circuit Les observations individuelles ont t compar es avec les moins de r gressions ci dessous la statistigue obtenue Diamond 0 988 x Beckman 0 634 mg dL r 0 999 n 45 intervalle 10 400 mg dL Si 3 17 mg dL R cup ration des valeurs attendues valu pour chaque matrix serum et urine Les dilutions des valeurs respectives ont t faites et mesur es avec les r actifs Diamond et Beckman Recovery Mesur es attendues x100 calcul pour les deux Diamond et Beckman Diamond et Beckman montrent les valeurs similaires dans chaque matrix Voir tableau 1 ci dessous Pr cision Serum et urine de control disponibles a la vente commerciale ont t essay s d util
13. Reference Ranges The values given as reference ranges are intended only as a guide rather than as absolute values No account is taken for age sex or dietary differences that may exist Each lab should establish a reference range based on their patient population Sample Type SI Units Serum or Plasma 0 6 to 1 2 mg dL Urine timed 0 8 to 2g 24hrs Performance Characteristics Performance data was collected on CXO3 Delta and CX 9ALX Systems Method Comparison Diamond Creatinine Reagent was compared to Beckman Reagent using spiked or diluted serum samples run in triplicate and tested with each reagent Diamond Creatinine Reagent and Beckman Creatinine Reagent Recoveries of individual observations were compared by least squares regression and the following statistics were obtained Diamond 0 988 x Beckman 0 634 mg dL r 0 999 n 45 range 10 to 400 mg dL Syx 3 17 mg dL Recovery to Expected Values Was evaluated for each matrix serum and urine Dilutions of the respective matrices were made and measured with Diamond and Beckman reagent Recovery Measured expected x100 was calculated for both Diamond and Beckman Diamond and Beckman exhibited similar recoveries across the range of values in all matrices See table 1 below Precision Commercially available control sera and urine controls were assayed using both Diamond and Beckman Creatinine Reagents on Synchron CX Delta System Samples were run for 20 days 2 runs per
14. Buffers gepuffert Natriumborat und Natrium phosphat Tensid und Konzervierung Picric Acid L sung 3 x 400 mL enth lt 0 05 M Picric Acid F r in vitro diagnostic verwenden Warnung Normale Vorsichtsmassnahmen im Labor ergreifen Wenn Ihre Haut in Ber hrung kommt dann muss die Oberfl che der Haut mit Wasser abgesp lt werden Wenn mit den Augen in Ber hrung kommt dann muss sofort mit klarem Wasser gesp lt werden In dem Fall einer versehntlichen Einnahme wenden Sie sich sofort zu den Arzt Sie sollen Schutzkleidung und Schutzbrille tragen w hrend der Arrbeit weil die S ure tzend f r die Kleidung und f r die Haut Lagerung amp Haltbarkeit Die alkalische Bufferl sung und Pikrins ure kann innerhalb des Ablaufsdatums benutzt werden welches Ablaufsdatum auf der Flasche darauf stehen soll Der kombinierte Reagenz kann noch ab dem Zeitpunkt der Vermischung 30 Tage lang benutzt werden wenn sie stabil richtig bei Raumtemperatur gelagert werden Lagern Sie es bei Raumtemperatur 18 25 C Sie d rfen die L sung nicht einfrieren oder abk hlen Ausscheidung kann bei niedriegen Temperature auftreten Die Ausscheidung wird aufgel st wenn das 37 C aufgewarmt wird Solange sollen Sie es nicht verwenden bis die die Auscheiderung nicht aufgel st ist Sie sollen es vor dem Gebrauch mischen Prozess Es wird von dem Hersteller gehandelt bestehenden Material ersetzt Sie sollen es solange nicht vorbereiten solange bis Sie nicht benutzen Die funktioni
15. Ogni laboratorio dovrebbe stabilire una gamma di riferimento in base alla loro popolazione di pazienti Sample Type SI Units Serum or Plasma 0 6 to 1 2 mg dL Urine timed 0 8 to 2g 24hrs Prestazione delle Charatteristiche La data del performance era collezionato su CX 3 Delta and CX 9ALX Systems Metodo di Confronto Diamond Creatinina Reagente stato rispetto a Beckman Reagente utilizzato a spillo o diluiti campioni di siero correre in triplice copia e testato con ogni reagente Diamond Creatinina Reagente e Beckman Glucose Reagente Recuperi di singoli osservazioni sono stati confrontati con regressioni al minimo e i seguenti statistiche sono state ottenute Diamond 0 988 x Beckman 0 634 mg dL r 0 999 n 45 range 10 to 400 mg dL Syx 3 17 mg dL Recupero dei Valori Attesi Per ogni matrice erano valutati siero e urine Le diluzioni delle matrici rispettivi sono stati fatti e misurati con Diamond e Beckman reagenti Ricovero Misaurato atteso x100 stato calcolato per Diamond e Beckman Diamond e Beckman hanno esposto recuperi simili attraverso la gamma di valori in tutte le matrici Guardare la tabella 1 sotto Precisioni Il controllo disponibile nel commercio i controlli di sieri e urine sono stati analizzati usando sia Diamond che Beckman Creatinina Reagenti su Synchron CX Delta System campioni hanno corso per 20 giorni 2 corse al giorno 2 osservazioni per corsa Guardare la tabella 2 sotto
16. Recuper ri de observa ii individuale au fost comparate cu metoda celor mai mici p trate i urm toarele statistici au fost ob inute Diamond 0 988 x Beckman 0 634 mg dL r 0 999 n 45 range 10 400 mg dL 3 17 mg dL Recuperarea valorilor a teptate A fost evaluat pentru fiecare matrice ser i urin Diluarea matricelor respective au fost f cute i m surate cu solu ie Diamond i Beckman Ecua ia Recuperare m surat asteptat x100 a fost calculat cu am ndou solu ii Solu iile Diamond i Beckman au ar tat valori recuperate similare n matrici A se vedea tabela nr 1 Precizie Solu ii de control pentru ser i urin au fost analizate cu solu ie creatin Diamond i Beckman pe analizor Synchron CX Delta Mostrele au fost analizate timp de 20 de zile 2 analize pe zi 2 observa ii pe analiz A se vedea tabela nr 2 1 2 Interval Medie Medie Matrix pd a i Solutie mediat Total N mg dL Pe analiz sd Total sd E Diamond Recuperare Recuperare Serum Control 1 80 1 6 0 07 0 14 Ser 9 04 0 20 mg dL Beckman 934 1143 104 2 Serum Control 2 80 6 9 0 10 0 62 7 3 Diamond 87 1021 96 Urine Control 1 80 89 0 7 10 9 van 00 1O mge Beckman 83 102 9 96 2 Urine Control 2 80 217 22 9 5 Literatur de referent Jaffe M Z Physiological Chemistry 10 391 1886 2 Tietz N W ed Clinica
17. amp Estabilidad Las soluciones de Alcalina y de Pictric se mantienen estables hasta la fecha de vencimiento marcada en la botella No se debe usar este producto mas alla de la fecha indicada Si se mantiene en temperatura ambiental el reactivo resultante se mantiene v lido por 30 d as desde el momento que se guarda la mezcla Se recomienda mantenerlo parado en temperatura de 18 25 C No congelar refrigerar la soluci n el reactivo a mezclar En temperaturas bajas puede ocurrir alguna precipitaci n Si se sobrecalienta encima de 37 C la precipitaci n se diluir No usar hasta que toda la precipitaci n se haya disuelto Mezclar por inversion antes de usar Procedimiento Debe server como reemplazo directo a materials existents distribuidos por el fabricante original OEM No prepare el reactivo hasta que este listo a ser usado Antes de instalar el instrumento prepare la solucion combinada siga los siguientes vertir una botella de solucion de acido Picric en una botella de reactvo buffer de Alcalina tapando y mezclando por inversion Para una descripcion detallada sobre el uso de este reactivo por favor referirse al manual del Operador del instrumento Control de Calidad Diamond Diagnostics sugiere el uso de material de control disponible que incluya valores ensayados para el instrumento que se esta usando Estos controles deber ser usados en niveles normales y anormales Diamond Diagnotics sugiere medir los controls antes de proced
18. hogy a reagensek s a bels kalibr ci s folyad kok val ban az adott k sz l kt pushoz val ak e szavatoss guk nem j rt e le illetve nem tartalmaznak e szemmel l that szennyez d st K vesse a Felhaszn l i K zik nyv Hibaelh r t s c m r sz ben foglaltakat V gezze el az sszes vonatkoz Karbantart si Proced r t amelyet a Felhaszn l i K zik nyv javasol Ha a probl m k tov bbra is fenn llnak l pjen kapcsolatba Technikai Ugyf lszolg latunkkal The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 11 of 20 D i A M O N D Creatine Reagenz Beckman Synchron CX 8 CX Delta Analyzers DIAGNOSTICS BK 443340D Hungarian Felhaszn l si Tartom ny A kreatin az al bbi felhaszn l si tartom nyban haszn lhat 0 6 to 25 mg dL Sz rum vagy Plazma eset ben 10 to 400 mg dL Vizelet eset ben Azokat a mint kat amelyekben a koncentr ci t ll pi a felhaszn l si tartom ny fels hat r t fel kell higitani ioncser lt v zzel vagy fiziol gi s s oldattal s megism telni az anal zist Funkcion lis rz kenys g Megk zel t leg 0 9 mg dL koncentr ci j kezd sz rumb l k sz ltek a sz rummin
19. jeder Matrix Serum und Urine bewertet Verd nnungen der jeweiligen Matrixen wurden gemessen mit Diamond und Beckman Reagenzen Aufschwung gemessen erwartet x100 wurde kalkuliert fur beide Diamond und Beckman Diamond und Beckman zeigten hnliche Aufschwung in den Bereich der Werte in allen Matrixen Siehe Tabelle 1 unten Pr zision Kommerziell erh ltliche Kontrollserum und Urin kontrolliert wurde unter Verwendung sowohl Diamond und Beckman Kreatinin Reagenzen auf Synchron CXO Delta System Die Proben wurden 20 Tage lang kontrolliert 2 sind t glich gelaufen 2 Beobachtungen per Lauf Siehe die Tabelle 2 unten 1 2 Reich ve ie Bereich der Insgesamt Durchschnitt Lauf Total Matrix Reagenz durchschnittlichen mittlere N dL innerhalb d erwartete 3 k mg d 5 mg dL Aufschwung Wiederfindung s Serum 904 0 20 Diamond 85 7 105 3 98 5 ci 80 1 6 0 07 0 14 erum mg dl Beckman 93 4 114 3 104 2 ontrol 1 E 400 10 Diamond 87 102 1 96 Serum 80 6 9 0 10 0 62 mg dL Beckman 83 102 9 96 2 Kontrol 2 Urine Kontrol 80 89 0 7 10 9 1 Urine Kontrol 80 217 2 2 9 5 Literatur Referenzen 1 Jaffe M Z Physiological Chemistry 10 391 1886 2 Tietz N W ed Clinical Guide to Laboratory Tests 2 Edition W B Saunders Company Philadelphia 1994 3 Henry John Bernard Clinical Diagnosis and Management by Laboratory Met
20. mL containing 0 05 M Picric Acid For in vitro diagnostic use only Cautions Exercise normal laboratory precautions If contact occurs with skin rinse affected area with water If contact with eyes occurs immediately rinse with copious amount of clean water or eye rinse In cases of accidental ingestion contact a physician immediately Protective clothing and gloves should be worn when handling the picric solution and working solution as the picric acid stains both skin and clothing Storage amp Stability The alkaline buffer and picric solution are stable until the expiration date listed on the bottle The product should not be used beyond this date The combined working reagent is stable for 30 days from the time of mixing if stored properly at ambient temperatures Store upright at room temperature 18 25 C Do not freeze or refrigerate the solution or working reagent Precipitation may occur at low temperatures The precipitate will dissolve when warmed at 37 C Do not use until all of the precipitate has dissolved Mix by inversion before use Procedure Intended to serve as a direct replacement to pre existing materials distributed by the OEM Do not prepare working reagent until ready to use The working solution is prepared prior to installing on the instrument by pouring a bottle of Picric Acid solution into a bottle of the Alkaline Buffer Reagent capping and mixing by gentle inversion For a detailed description of the use of
21. may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 4 of 20 DIAMOND Creatine Reagent Beckman Synchron CX amp CX Delta Analyzers BK 443340D Czech DIAGN OS Tic amp Diamond Diagnostics 333 Fiske Street Holliston MA Technicka asistence na C sle Diamond Diagnostics technicky servis 1 508 429 0450 Doporu en pouzit Reagen n sada pro stanoven Kreatinu je ur ena pro kvantitativn detekci kreatininu v s ru plasm i mo i syst mech Beckman Synchron CX amp CX Delta Shrnut a princip Produkt je ekvivalentem OEM zkratka z anglick ho Orginal Eguipment Manufacturer Sv mi parametry funk nost a kvalitou pln nahrazuje nutnost pou it originaln ho produktu distribuoavan ho p vodn m v robcem Klinick v znam Stanoven koncentrace Kreatininu se pou v pro diagn zu a l bu ledvinov ch onemocn n dial ze a jako normaliza n faktor p i m en dal ch mo ov ch analyt Metodika Pro stanoven kreatininu se vyu v jednoduch Jaff ho reakce Principem je reakce kreatininu s pikr tem kyselina pikrov v alkalick m prost ed Anion kreatininu se spoj s pozitivn polarizovan m uhl kem pikr tov ho iontu za vzniku erveno oran ov ho komplexu Kreatinine
22. mg dL con reactivo de Beckman Los valos que se proveen como rangos de referencia deben servir nicamente como gu as en vez de valores absolutos No se toma en cuenta la edad el sexo o cualquier diferencia alimenticia que pueda existir Cada laboratorio debe establecer un rango de referencia propio basado en su propia poblacion de pacientes Tipo de Muestra SI Unidades Suero o Plasma 0 6 to 1 2 mg dL Orina medida 0 8 to 2g 24hrs Comparaci n del M todo Caracteristicas de la Performancia Se ha coleccionado data de performancia los Sistemas Delta y CX 9ALX Recuperaci n de Valores Esperados Fue evaluada para cada matriz suero y orina Las diluciones de las matrices respectivas fueron El reactivo de Creatina de Diamond se compar con el reactivo de Beckman usando muestras dilu das o combinadas y se hizo una prueba en triplicado usando cada reactivo el de Diamond y el de Beckman La recolecci n de cada observaci n fu comparada con una regresi n least squares y las siguientes estadisticas fueron obtenidas Diamond 0 988 x Beckman 0 634 mg dL r 0 999 n 45 rango 10 a 400 mg dL Syx 3 17 mg dL efectuadas y medidas con los reactivos de Diamond y de Beckman Recuperaci n Medido esperado x100 fu calculado para Diamond y para Beckman Diamond y Beckman presentaron recuperaciones similares a trav s de los rangos de valor en todas las matrices Ver la Tabla 1 m s abajo
23. n metod Diamond Kreatinin reagent byl porovn n s Beckman reagentem za pou it vzork s ra s vnit n m p davkem standardu nebo na ed n ho s ra Vzorky byly analyzov ny s ka d m reagentem t ikr t N vratnost jednotliv ch m en byly porovn ny line rn regres s n sleduj c mi v sledky Diamond 0 988 x Beckman 0 634 mg dL r 0 999 n 45 rozsah 10 a 400 mg dL 3 17 mg dL N vratnost o ek van ch hodnot Byla stanovena pro ka dou matrici s rum a mo Na ed n vzorky byly m eny s pou it m reagent Diamond a Beckman N vratnost Nam en hodnota o ek van hodnota x100 byla spo t na pro oba reagenty Diamond i Beckman Diamond a Beckman vykazuj podobn n vratnosti p es rozsah hodnot ve v ech matric ch Tabulka 1 dole P esnost Komer n dostupn kontroln s ra a mo byly analyzov ny s pou it m obou Diamond a Beckman Kreatininov ch reagent na syst mech Synchron CX Delta Vzorky byly analyzov ny po 20 dn ve dvou setech za den dv m en duplik t v ka d m setu Tabulka 2 dole 1 2 Matrice vzorek o ek van Reagent eue pr m rn SD koncentrace 9 n vratnost Kontroln s rum 1 80 1 6 0 07 0 14 mg dL recovery Kontroln s rum 2 80 6 9 0 10 0 62 4 Diamond 85 7 105 3 98 5 i mo S rum 9 04 0 20 Kontrolni mo 1 80 89 0 7 10 9 Beckma
24. this reagent refer to the Instrument s Operator Manual Quality Control Diamond Diagnostics suggests the use of commercially available control material with results assayed for the instrument used Controls should be run at Normal and Abnormal levels Diamond Diagnostics suggests measuring controls before patient samples are run and following instrument maintenance Serum Plasma or Urine are the sample of choice whole blood samples are not recommended Compatible anticoagulants or Chemical additives with this method are Anticoagulants Acceptable Level Anticoagulants Acceptable Level Anticoagulants Acceptable Level Sodium Citrate 3 5 mg mL Ammonium Heparin 45 Units mL Sodium Heparin 45 Units mL EDTA 4 0 mg mL Lithium Heparin 45 Units mL Lithium lodoacetate 1 5 mg mL Specimens collected in a tube containing liquid Sodium Citrate will exhibit a decrease in value to dilution effect Lipemic samples gt 3 should be ultracentrifuged and the analysis performed on the supernatant Refer to Literature References 2 and 3 for other interferences caused by drugs and disease If the instrument fails calibration or controls do not measure within acceptable range when Diamond Diagnostics products are used Diamond Diagnostics suggests the following Verify that the reagents and internal calibrators used to standardize the instrument are correct for the instrument have adequate expiration and do not contain visually evident contamination Fo
25. 0 nm la 25 6 secunde dup alimentarea mostrei Diferen a ntre absorbant se poate m sura i este direct propor ional cu concentra ia creatininei n mostr Solu ii Kit Sollutie Creatin BK 443340D Con ine Buffer Alkalin 3 x 1600 mL este o solu ie apoas care con ine 0 188 mmol L NaOH Buffer cu borat de sodiu fosfat de sodiu tenside si conservanti Solutie de Acid Picric 3 x 400 mL con ine 0 05 M Acid Picric Pentru utilizare in vitro Precautii Exercitati m suri de precau ie normale de laborator n caz de contact cu pielea cl titi zona afectat cu ap n caz de contact cu ochii cl titi imediat cu o cantitate mare de ap curat sau cu solu ie pentru cl tirea ochiilor n caz de inghitire accidental contacta i imediat un medic Purtati mbr c minte i m nu i de protec ie n momentul manipul rii a solu iei picric deoarece acidul picric p teaz piele i mbr c mintea Expirare i Depozitare Data expir rii a solu ie picric i buffer alkalin se afl pe flaconul produsului A nu se folosi produsul dup aceast dat Solu ia de lucru deja amestecat este stabil 30 de zile de la data de amestecare dac este p strat la temperatura camerei A se p stra n pozi ie vertical la temperatura camerei 18 25 C Nu congelati sau refrigerati solu iile La temperature reduse se produce precipitatie Precipitatul se dizolv nc lzit la 37 C Nu folosi i solu ia p n c nd pre
26. 3340D Bulgarian Diamond Diagnostics 333 Fiske Street Holliston ce Diamond Diagnostics Technical Services at 1 508 429 0450 DIA GNOSTICS Creatine Reagent Beckman Synchron CX amp CX Delta Systems ONO Creatinine Picric Acid
27. DIAMOIND Creatine Reagent Beckman Synchron CX amp CX Delta Analyzers BK 443340D Diamond Diagnostics 333 Fiske Street Holliston MA For Technical Assistance call Diamond Diagnostics Technical Services at 1 508 429 0450 DA F Intended Use Creatine Reagent is for the quantitative determination of creatinine in serum plasma or urine on the Beckman Synchron CX amp CX Delta Systems Summary And Principle This product is intended to serve as a functional equivalent to pre existing material distributed by the Original Equipment Manufacturer OEM Clinical Significance Creatinine measurements are used in the diagnosis and treatment of renal diseases in renal dialysis and as a calculation basis for measuring other urine analytes Methodology Creatinine is determined by mixing a sample with the alkaline picric reagent creatinine from the sample combines with the reagent to produce a red colored complex Creatinine Picric Acid Creatinine Picrate Complex red Absorbance readings are taken at both 520 nm and 560 nm at 25 6 seconds after sample addition The differential absorbance is a direct measure of the concentration of creatinine in the sample Reagents Creatine Reagent Kit BK 443340D Containing Alkaline Buffer 3 x 1600mL is an aqueous solution containing of 0 188 mol L NaOH Buffers buffered with sodium borate and sodium phosphate surfactant and preservative Picric Acid Solution 3 x 400
28. L din cauza dilutiei mostrele colectate ntr un tub care con ine citrat de sodiu lichid vor prezenta o sc dere a valorii Mostra lipemic gt 3 trebuie ultra centrifugat si analiza trebuie efectuat pe solu ia limpezit A se vedea Literatura de Referin 2 i 3 pentru interferen e diferite cauzate de medicamente i boli Dac folosind produse Diamond Diagnostics instrumentul nu calibreaz sau solu iile de control nu m soar in intervalul acceptabil urm ri i urm toarele puncte Verifica i dac solu iile i calibratorii internale folosite pentru standardizarea instrumentului s nt corecte pentru instrument nu s nt expirate i nu s nt contaminate Urmati procedurile aflate n manualul de utilizare n capitolul Troubleshooting Remedierea Defectiunii Verifica i dac procedurile de ntre inere aflate n manualul de utilizare s au realizat Dac problema exist n continuare contacta i Serviciul Technic Diamond Diagnostics The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 17 of 20 DIAMOND Solutie Creatin SA E NE EA TECE Analizori Beckman Synchron CX amp CX Delta BK 443340D Romanina
29. The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 13 of 20 D i A M O N D Creatine Reagenz Beckman Synchron CX 8 CX Delta Analyzers DIAGNOSTICS BK 443340D Italian Gamma utilizzabile Creatinina stata trovata per avere le seguente gamme utilizzabili 0 6 to 25 mg dl per Siero o Plasma 10 to 400 mg dl in Urine I campioni con concentrazione superiore al limite massimo della gamma utilizzabile estrema dovrebbero essere diluiti con acqua deionizzata o con soluzione salina e reanalizzati Sensibilit Funzionale campioni di siero valutati in diluzioni fatti dal serum dell inizio di una concentrazione di circa 0 9 mg dL diluzioni erano 1 3 1 5 1 11 e un 0 mg dL campioni erano testati come 4 campioni per corsa sopra 5 corsi di calibrazione II livello piu basso dove un CV meno di 20 era raggiunto con la diluzione su un valore atteso di 0 9 mg dL BUN la quale ricoverato come 0 6 mg dL con Diamond reagente 0 8 mg dL con Beckman reagente Referenze di Gamme valori dati come referenze di gamme sono destinati solo come guida pi ttosto che valori assoluti Non si tiene conto per et sesso or differenze alimentari che potrebbero esistere
30. a 10 to 400 mg dl in Urine Diejenigen Proben deren Konzentrationen die obere Messbereich bersteigen sollten sie mit deionisiertem wasser oder mit Salz verd nnt und soll wieder kontrolliert werden Funktional Empfindlichkeit n der gel ste Seriumprobe derer Konzentration 0 9 mg dL war wurde alle Test fertig gemacht Verd nnungen waren 1 3 1 5 1 11 and a 0 mg dL Proben wurden getestet als 4 Proben per Lauf ber 5 Lauf Kaliebriert Die unterste Ebene wo die Anzahl der CV war weniger als 20 ist diese Ebene mit dieser L sung erreicht hat wo der Wert 0 9 mg dl Bun gewesen ist 0 6 mg dL mit Diamond Ragenz 0 8 mg dL mit Beckman Reagenz Referenzbereiche Die Werte sind angegeben als Referenzbereiche nur als Leitfaden und als absolute Werte Es wurde der Alter geschlecht nicht in R cksicht genommen Jedes Labor sollte ein Referenzbereich auf Ihrer Bev lkerungpopulation schaffen Probe Typ SI Units Serum oder Plasma 0 6 to 1 2 mg dL Urine timed 0 8 to 2g 24hrs Leistungsmerkmale Performance Daten wurden gesammelt auf CX 3 Delta and CX 9ALX Systems Methodenvergleich Diamond Kreatinin Reagenz wurde mit Beckman Reagenz vergliechen wo die Probeserum 3 mal laufen lassen wurde und jeder Reagenz getestet Laut der einzelnen Beobachtung wir haben die folgende statistische Angaben bekommen Diamond 0 988 x Beckman 0 634 mg dL r 0 999 n 45 range 10 to 400 mg dL Sy 3 17 mg dL Aufschwung der Erwartete Werte Es wurde f r
31. ado O n vel mais baixo onde um CV de menos de 20 se conseguiu foi com a dilui o de um valor esperado de 0 9 mg dL BUN que recuperou como 0 6 mg dL com reagente de Diamond 0 8 mg dL com reagente de Beckman Intervalos de Refer ncias Os valores apresentados como valores de refer ncia destinam se apenas como um guia e n o como valores absolutos N o s o tidos em conta para a idade sexo ou diferen as na dieta que podem existir Cada laborat rio deve estabelecer um intervalo de refer ncia com base em sua popula o de pacientes Tipo de Amostra SI Units Soro ou Plasma 0 6 to 1 2 mg dL Urina cronometrado 0 8 to 2g 24hrs Caracter sticas de Desempenho Dados de desempenho foram coletados em CX 3 Delta e CXO9ALX Sistemas Compara o de M todo Diamond Reagente de Creatina foi comparado com Beckman Reagente usando spiked ou dilu do amostras de soro executar em triplicado e testados com cada reagente Diamond Reagente de Creatinina e Beckman Reagente de Creatinina Recupera es de observa es individuais foram comparadas por regress o por m nimos quadrados e as estat sticas foram obtidos os seguintes Diamond 0 988 x Beckman 0 634 mg dL 0 999 n 45 varia o 10 to 400 mg dL Sy 3 17 mg dL Recupera o para Valores Esperados Foi avaliada para cada matriz soro e na urina Dilui es das respectivas matrizes foram feitas e medidas com Diamond e Beckman reagente Recupera o Medidos esperado
32. anormal Diamond Diagnostics propose de faire un test de mesure avant d utiliser les chantillons du patient et suivre les instructions de maintenance Limitations Serum Plasma ou Urine sont des chantillons de choix toutes les chantillons de sang ne sont pas conseill es 4 5 Anticoagulants ou additives chimiques compatibles avec cette m thode Anticoagulants Niveau acceptable Anticoagulants Niveau acceptable Anticoagulants Niveau acceptable Sodium Citrate 3 5 mg mL Ammonium Heparin 45 Units mL Sodium Heparin 45 Units mL EDTA 4 0 mg mL Lithium Heparin 45 Units mL Lithium lodoacetate 1 5 mg mL Sp cimens chantillons collect es dans un tube qui contient de la liquide de Sodium Citrate pr senteront une baisse de valeur pour l effet de dilution Les chantillons lip miques gt 3 doivent etre ultra centrifug s et les analyses refaites sur la couche sous jacente Se r f rer aux R f rences 2 et 3 pour les autres interf rences g n r es par des m dicaments et des maladies Lors de l utilisation du produit Diamond Diagnostics si r sultat de mesure est hors des valeurs acceptables suivez les instructions ci dessous V rifiez si les calibrateurs internes utilis s pour la standardisation de l appareil sont bien conformes la date de p remption et de ne pas avoir de contaminations visibles Suivez les proc dures se trouvant dans le Manuel d Utilisation des Appareils voir chapitre D pannage V rifiez si tous les p
33. c Brea CA The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 16 of 20 DIAMOND Solutie Creatin Analizori Beckman Synchron CX amp CX Delta BK 443340D Romanina Informa ii despre produs i produc tor Diamond Diagnostics 333 Fiske Street Holliston MA Pentru asisten technic apelati la Serviciul Technic Diamond Diagnostics 1 508 429 0450 DIAGN OS Tic amp Utilizare Solu ia Creatina este folosit pentru a determina cantitatea creatininei in ser plasma i urin pe analizori Beckman Synchron CX amp CX Delta Rezumat si Principiu Acest produs este destinat sa serveasca un echivalent functional pentru materiale existente distribuite de producatori originale OEM Importanta Clinica M surarea creatininei se folose te n diagnosticarea i tratamentele bolilor renale dializ renal i ca baz de m surare a diferite analiti n urin Metodologie Cantitatea creatinin se determin prin amestecarea mostrei cu picrat alkalin creatinina din mostr se combin cu reactivul form nd un complex ro u Creatinin Acid Picric Creatinin Picrat Complex ro u Absorbanta este citit la 520 nm i 56
34. cipitatul se dizolv de tot Amestecati solu iile prin r sturnarea flaconului nainte de folosire Procedur Procedur Acest produs este destinat s serveasc un echivalent func ional pentru materiale existente distribuite de OEM Nu amestecati solu iile anticipat Solutia de lucru trebuie preparat nainte de instalare n instrument Pentru preparare goliti flaconul de Acid Picric n flaconul solu iei Buffer Alkalin pune i capacul la loc i amesteca i cu inversare u oar Pentru o descriere detaliat a utiliz rii acestui produs a se vedea manualul de utilizare a instrumentului Controlul Calit ii Diamond Diagnostics propune utilizarea materialelor de control disponibile pe pia cu rezultate analizate pentru diferite instrumente Solu iile de control trebuie evaluate n niveluri normale i anormale Diamond Diagnostics sugereaz folosirea solu iilor de control nainte de a evalua mostre de la pacien i i dup ntre inerea instrumentelor Mostre de ser plasm i urin s nt recomandate Mostra de s nge integral nu este recomandat Anticoagulante sau agenti aditive chimice compatibile cu aceast metod sunt Anticoagulante Valoarea acceptabil Anticoagulante Valoarea acceptabil Anticoagulante Valoarea acceptabil Citrat de sodiu 3 5 mg mL Heparin de ammoniu 45 unitate mL Heparin de sodiu 45 unitate mL EDTA 4 0 mg mL Heparin de litiu 45 unitate mL Litiu iodoacetic 1 5 mg m
35. das para el diagn stico y tratamiento de enfermedades renales en di lisis del ri on y como base para calcular otros par metros que miden la orina Metodolog a La Creatinina se determina mezclando una muestra con el reactivo alcalino picrico la creatinina de esta muestra se combina con el reactivo para producir una complejo de color rojo Creatinina Acido Picric Complejo de Creatinina Picrate rojo Las lecturas de absorbancia se toman despu s de sumar las muestras en 25 6 segundos en ambos casos de 520nm y 56nm El diferencial de la absorbencia es una medida directa de la concentraci n de la creatinina en la muestra Reactivos Equipo de reactivo de Creatina BK 443340D Contenido Buffer de Alcalina 3 x 1600mL es una soluci n acuosa que contiene 0 188 mol L NaOH Buffers cubiertos con borato de sodio y fosfato de sodio surfactante y conservante Soluci n de cido Picric 3 x 400 mL contiene 0 05 M cido Picric Para uso diagnostico in vitro Advertencias Se recomienda usar las mismas precauciones que para cualquier laboratorio Si hace contacto con piel enjuagar el rea afectada con agua Si hay contacto con los ojos enjuagar abudantemente inmediatamente con agua o enjuagador de ojos En caso de ingerir el producto accidentalmente contactar a un Doctor de inmediato Cuando se usas las soluciones Pcric y de trabajo se debe usar ropa y guantes protectores ya que el cido picric mancha la piel y la ropa Almacenamiento
36. day 2 observations per run See table 2 below 1 2 Range of Overall Mean within Total Matrix Reagent average Mean N mg dL run sd sd Diamond pee Serum Control 1 80 1 6 0 07 0 14 Serum 9 04 0 20 mg dL Beckman 934 1143 104 2 Serum Control 2 80 6 9 0 10 0 62 An Diamond 87 1021 96 Urine Control 1 80 89 0 7 10 9 ur Zins Beckman 83 1029 96 2 Urine Control 2 80 217 2 2 9 5 Literature References 1 Jaffe M Z Physiological Chemistry 10 391 1886 2 Tietz N W ed Clinical Guide to Laboratory Tests 2 Edition W B Saunders Company Philadelphia 1994 3 Henry John Bernard Clinical Diagnosis and Management by Laboratory Methods 20 Edition W B Saunders Company Philadelphia 2001 4 SYNCHRON CX 3 Delta Clinical System Operating Instructions Beckman Instruments Inc Brea CA SYNCHRON CX 3 Clinical System Operating Instructions Beckman Instruments Inc Brea CA The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 2 of 20 DIAMOIND Creatine Reagent Beckman Synchron CX amp CX Delta Analyzers BK 44
37. dos han sido aplicados seg n el Manual del Operador The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 19 of 20 D 1 M O N D Reactivo de Creatina DIAGNOS Analizadores Beckman Synchron CX 8 CX Delta TICS BK 443340D Spanish Si el problem persiste cont ctese con el Departamento de Servicio T cnico de Diamond Diagnostics Rango utilizable Sensitividad Funcional Rangos de referencia Se encontro que la Creatina tiene el siguiente rango utilizables 0 6 to 25 mg dl para Suero o Plasma 10 to 400 mg dl in Orina Muestras con concentraciones que exceden el m ximo del rango utilizables deben ser dilu das con agua desionizada o con sal y re analizadas Evaluada en la diluci n de muestras de suero fabricado empezando por un suero inicial con las concentraciones aproximadas de 0 9 mg aL las diluciones fueron 1 3 1 5 1 11 y un O mg dL Estas muestras fueron probadas como 4 muestras por cada prueba sobre 5 calibraciones Los niveles m s bajos fueron un CV de menos de 20 que se consiguieron con una diluci n a un valor esperado de 0 9 mg dL BUN lo que permiti recuperar 0 6 mg dL con reactivo de Diamond 0 8
38. ed by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECOK 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 5 of 20 DIAMOND Creatine Reagent BA TE E SE A Beckman Synchron CX amp CX Delta Analyzers BK 443340D Czech Rozsah pouzitelnosti Kreatinin m nasledujici rozsah pouziti 0 6 az 25 mg dl v s ru Ci plasm 10 az 400 mg dl v mo i Vzorky s koncentrac vy nez horn hranice rozsahu pou it by m ly byt p ed anal zou na ed ny destilovanou vodou nebo fyziologick m roztokem Funk n senzitivita Byla stanovena na na ed n ch vzorc ch p ipraven ch ze s ra p vodn koncentrace p ibli n 0 9 mg dL ed n byly n sleduj c 1 3 1 5 1 11 a O mg dL Vzorky byly testov ny v setu po ty ech po p ti kalibra n ch setech koncentrac 0 9 mg dL BUN byla 0 6 mg dL s reagentem Diamond 0 8 mg dL s reagentem Beckman Referencn rozsah hodnoty Hodnoty uveden jako referen n hodnoty jsou ur eny pouze jako ukazatel nikoliv jako absolutn hodnoty V vahu nejsou br ny rozd ly zp soben v kem pohlav m i dietou Ka d laborato by m la stanovit referen n hodnoty na z klad populace pacient Typ vzorku SI jednotky S rum nebo Plasma 0 6 a 1 2 mg dL Mo 0 8 a 29 24hodin Data v konnosti byly nam eny na syst mech CX83 Delta a CX 9ALX Porovn
39. edni ce P edejdete tak tvorb sra enin kter vznik j v d sledku skladov n p i n zk ch teplot ch Sra eniny Ize rozpustit zah t m na 37 C Nepou vejte dokud se sra eniny zcela nerozpust P ed pou it m promixujte jemn m p evr cen m l hve Postup Produkt je ekvivalentem OEM Sv mi parametry funk nost a kvalitou pln nahrazuje nutnost pou it originaln ho produktu distribuoavaneho p vodn m v robcem Reagenty nep ipravujte d ve ne p ed jejich pl novan m pou it m Pracovn roztok se p ipravuje t sn p ed jeho instalac na instrument vm chan m cel ho obsahu l hve kyseliny pikrov do l hve alkalick ho pufru P ed pou it m sm s zam chejte p evr cen m uzav en l hve Detailn instrukce pou it reagentu naleznete v u ivatelsk p r ce instrumentu Kvalita jakosti Diamond Diagnostics doporu uje pou t komer n dostupn ho kontroln ho materi lu vzork pufr apod se specifick mi hodnotami pro v typ instrumentu Kontroln vzorky by m ly b t zvoleny tak aby pokr valy referen n rozmez norm ln zdrav vzorky a hodnoty o ek van pro vzorky pacient abnorm ln hodnoty Diamond Diagnostics doporu uje analyzovat kontroln vzorky p ed vlastn m m en m vzork pacienta s proveden m n sledn pravideln d by instrumentu Je doporu eno pou vat vzorky s ra plasmy nebo mo i krev pro tuto anal zu nen vhodn Antikoa
40. eket Norm lis s Abnorm lis szinteken egyar nt c lszer elv gezni A Diamond Diagnostics azt tan csolja hogy v gezzen m r steszteket miel tt a v rmint kat teszteln illetve k vesse a k sz l k karbantart s ra vonatkoz utas t sokat Korl toz sok Az elemz st sz rumon plazm n vagy vizeleten v gezze teljes v rminta nem javasolt Az elemz shez a k vetkez antikoagul nsok vagy k miai adal kok haszn lhat ak Antikoagul nsok Elfogadhat szint Antikoagul nsok Elfogadhat szint Antikoagul nsok Elfogadhat szint N trium citr t 3 5 mg mL Amm nium Heparin 45 Units mL N trium Heparin 45 Units mL EDTA 4 0 mg mL L tium Heparin 45 Units mL Litium lodoacet t 1 5 mg mL Azok a mint k amelyek foly kony N trium citr tot tartalmaz k mcs be ker lnek higit s hat s ra cs kken rt ket mutatnak A 3 as rt k feletti rt ket mutat Lip mi s mint k eset ben ultracentrifug l sra van sz ks g s az anal zist a centrifug l s ut ni fel l sz folyad kon kell elv gezni K rj k olvassa el az Irodalmi Mutat 2 s 3 pontjait egy b interferenci kkal kapcsolatosan amelyek gy gyszerek s betegs gek hat s ra el ad dhatnak Amennyiben sikertelen a k sz l k kalibr l sa vagy a tesztel s eredm nye nem a megfelel tartom nyba esik a Diamond Diagnostics term keinek haszn latakor a Diamond Diagnostics az al bbi l p sek elv gz s t javasolja Ellen rizze
41. er lt felt ntet sre Ezen d tum ut n a term ket ne haszn lja A kikevert reagens szavatoss ga az elk sz t s napj t l sz m tott 30 nap amennyiben azt szobah m rs kleten s megfelel en t rolj k A term ket t rolja f gg legesen szobah m rs kleten 18 25 C on Ne fagyassza le s ne h tse se az oldatot se a kever ket Alacsony h m rs kleten kicsap d s lehets ges Ez felold dik amint jra 37 C os k zegbe ker lnek az anyagok Am g a kicsap dott r szek teljesen fel nem old dtak ne haszn lja az anyagokat Haszn lat el tt ford tsa fejjel lefel a palackot hogy sszekeveredjenek az sszetev k Proced ra Proced ra A term k azzal a c llal k sz lt hogy funkcion lisan helyettes tse a k sz l k gy rt ja OEM ltal forgalmazott eredeti term ket A felhaszn land kever ket csak akkor k sz tse el amikor k szen ll annak azonnali felhaszn l s ra Az oldatot k zvetlen l haszn lat el tt az al bbiak szerint k sz tse el nts n egy palack pikrinsavas oldatot a savas buffer reagens palackj ba z rja r a fed kupakot s a palack vatos oldalra d nt s vel keverje ssze A reagens haszn lat nak r szletes le r sa a k sz l k Felhaszn l i K zik nyv ben tal lhat Min s gellen rz s A Diamond Diagnostics javasolja a kereskedelmi forgalomban kaphat ellen rz minta haszn lat t amely az adott k sz l kre vonatkoz teszteredm nyeket tartalmazza A teszt
42. er con los especimenes de los pacientes y seguir el debido mantenimiento del instrumento Limitaciones Suero Plasma u orina son el tipo de muestra deseado No se recomienda usar muestras de sangre enteras Anticoagulantes o aditivos quimicos usados con este metodo son Anticoagulantes Nivel aceptable Anticoagulantes Nivel aceptable Anticoagulantes Nivel aceptable Sodium Citrate 3 5 mg mL Ammonium Heparin 45 Unidades mL Sodium Heparin 45 Unidades mL EDTA 4 0 mg mL Lithium Heparin 45 Unidades mL Lithium lodoacetate 1 5 mg mL Muestras coleccionadas en un tubo que contiene Citrato de Sodio liquido presentaran como resultado una disminuci n en el valor de diluci n Muestras Lipemicas gt 3 debe ser probado por la ultra centrifuga y los analysis hechos en el sobrante de liquidos Referirse al cap tulo de Referencias Literarias 2 y 3 para cualquier otro tipo de interferencia causada por drogas y enfermedades Si cuando se usan productos de Diamond Diagnostics y el instrumento falla la calibraci n 6 los controles no ofrecen rangos aceptables sugerimos hacer lo siguiente Verificar que los reactivos y calibradores internos usados para estandardizar el instrumentos sean los indicados para el instrumento tengan el vencimiento adecuado y no contienen ninguna evidencia visual de contaminaci n Siga los procedimientos delineados en el Manual del Operador bajo la secci n Ayuda Asegurese que todos los Procedimientos de Mantenimiento appropia
43. erende L sung ist vor der Installation auf dem Ger t erstellt giessen Sie eine Flasche Pikrins urel sung in einer Flasche des Alkoline Buffer Reagenz und mischen Sie es ganz vorsichtig F r die detaillierte Beschreibung der Verwendung dieses Reagens ist in der Bedienungsanleitung zu finden Qualit tskontrolle Diamond Diagnostics empfiehlt die Verwendung eines verf gbares Kontrol Materials welche Ergebnise im Handel schon analysiert wurden Die Kontrolle sollen auf normal und nicht normal Ebene laufen Diamond Diagnostics empfiehlt die Messung der Kontrolle bevor die Patientenproben in die Machine eingesetzt werden und folgen Sie die Anweisung fur die Verwendung Einschr nkungen Als Probe kann man Serum Plasma oder Urine w hlen der klare Blut ist nicht empf hlen 4 5 Chemische Zus tze oder Antikoagulantien mit dieser Methode sind Antikoagulantien Annembahre Ebene Antikoagulantien Annembahre Ebene Antikoagulantien Annembahre Ebene Natriumzitrat 3 5 mg mL Ammonium Heparin 45 Units mL Sodium Heparin 45 Units mL EDTA 4 0 mg mL Litium Heparin 45 Units mL Litium lodoacetate 1 5 mg mL Wenn Proben in R hrchen gesammelt werden welche fl ssige Natriumzitrat enthalten dadurch werden sie in dem Wert der Verw sserungseffekt eine R ckgang zeigen Lip mische Proben gt 3 soll centrifugiert werden Die centrifugierte L sung teilt sich und in dem Rest der Fl ssigkeit soll man den Test fertig machen Siehe Literaturverzeic
44. g dL 0 999 n 45 tartom ny 10 to 400 mg dL Sy 3 17 mg dL V rhat rt kek helyre ll t sa Minden m trixban rt kelt k sz rum s vizelet A m trixokhoz tartoz h g tott oldatokat k sz tett nk majd m rt k Diamond s Beckman reagensekkel is A helyre ll t st Helyre ll t s M rt V rt x100 rt k t kisz molltuk mindk t esetre A Diamond s a Beckman hasonl helyre ll t si rt ket mutatott a M TRIX teljes rt ktartom ny ban L sd az 1 t bl zatot lent Pontoss g A kereskedelemben el rhet sz rum s vizelet ellen rz mint kat pr b ltunk ki Diamond s Beckman Kreatinin Reagens haszn lat val Synchron CX Delta rendszeren A mint kat 20 napon t tesztelt k naponta kett t tesztel senk nt 2 megfigyel ssel L sd a 2 t bl zatot lent 1 2 V rhat E Atlagos N Atlag Sz r s Teljes Matrix Koncentr ci tartom ny Reagens feb Mia helyre i mg dL tesztenk nt sz r s mg dL y y ll t s Sz rumminta 1 80 1 6 0 07 0 14 mm e Diamond 857 1053 98 5 Sz rumminta 2 80 6 9 0 10 0 62 Ba ey mg Beckman 93 4 114 3 104 2 Vizeletminta 1 80 89 0 7 10 9 Diamond 87 102 1 96 Vizeletminta 2 80 217 2 2 9 5 Se Iene Beckman 83 1029 96 2 1 Jaffe M Z Physiological Chemistry 10 391 1886 2 Tietz N W ed Clinical Guide to Laboratory Tests 2 Ed
45. gulanty a chemick p sady kompatibiln s touto metodou jsou Antikoagulanty P pustn hodnoty Antikoagulanty P pustn hodnoty Antikoagulanty P pustn hodnoty Citr t sodn 3 5 mg mL Ammonium Heparin 45 jednotek mL Sodium Heparin 45 jednotek mL EDTA 4 0 mg mL Lithium Heparin 45 jednotek mL Lithium lodoacetate 1 5 mg mL Vzorky odebran do zkumavky obsahuj c vodn roztok citr tu sodn ho budou vykazovat ni hodnoty d ky na ed n Vzorky s vysok m obsahem tuk Lipemick vzorek gt 3 by m ly b t zcentrifugov ny a anal za by m la b t provedena v supernatantu Dal mo n interference zp soben l ky i nemocemi Ize nal zt v publikac ch 2 a uveden ch n e Pokud instrument nespln kalibra n paramentry nebo jsou li v sledky kontroln ch vzork mimo referen n limity Diamond Diagnostics doporu uje n sleduj c Zkontrolujte spr vnost typu pou it ch reagentu a intern ch standard jejich expira n lhutu a prove te vizu ln kontrolu zda neobsahuj ne istoty N sledujte instrukce pro odstran n z vady popsan v u ivatelsk p r ce instrumentu v kapitole z vady Ujist te se e byla provedena p edepsan dr ba instrumentu popsan v u ivatelsk p r ce Pokud probl m trv kontaktujte pros m Diamond Diagnostics technick servis The names of various manufacturers their instruments and their products referred to herein may be protect
46. hnis 2 und 3 und die Verursache der St rungen durch Medikamenten und andere Krankheiten Wenn die Kaliebrierung oder die Steuerung des Ger tes ausfallt wird es nicht innerhalb einer annehmbaren Wert gemessen wenn die Produkten von Diamond Diagnostics in Benutzung sind In diesem Fall Diamond Diagnostics empfiehlt die folgendes berzeugen Sie sich dass die Reagenzen und die innere Kalibratoren entsprechend sind zu dem Ger t und wann das Ablaufdatum ist bzw enth hlt keinen sichtbaren Schmutz Folgen Sie die Anweisungen in dieser Hinschicht was Sie in dem Anweisung Handbuch unter dem Kapitel Fehlerbehebung finden k nnen berpr fen Sie dass alle Wartungs Verfahren geeignet sind die in der Bedienungsanleitung enthalten Falls das Problem weiterhin besteht nehmen Sie den Kontakt mit der Technischer Abteilung von Diamond Diagnostics auf The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 9 of 20 D i A M O N D Creatine Reagenz Beckman Synchron CX amp CX Delta Analyzers aci dat ce i a BK 443340D German Nutzbarar Bereich Kreatin wurde festgestellt dass die folgenden nutzbaren Bereich haben 0 6 to 25 mg dl for Serum oder Plasm
47. hods 20 Edition W B Saunders Company Philadelphia 2001 4 SYNCHRON CX 3 Delta Clinical System Operating Instructions Beckman Instruments Inc Brea CA SYNCHRON CX 3 Clinical System Operating Instructions Beckman Instruments Inc Brea CA The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 10 of 20 D i A M O N D Creatine Reagenz Beckman Synchron CX amp CX Delta Analyzers DIAGNOSTICS BK 443340D Hungarian Inform ci k a Term kr l s a Gy rt r l Diamond Diagnostics 333 Fiske Street Holliston MA Technikai Segits g rt hivja az al bbi telefonsz mot Diamond Diagnostics Technikai Ugyf lszolg lat 1 508 429 0450 Felhaszn l s A Kreatin reagens a sz rumban plazmaban illetve vizeletben megtal lhat kreatinin mennyis gi meghat roz s ra _ szolg l Beckman Synchron CX s CX Delta k sz l keken Osszegz s s Alapelv Ez a term k azzal a c llal k sz lt hogy funkcion lisan helyettes tse a k sz l k gy rt ja OEM ltal forgalmazott eredeti term ket Klinikai Jelent s g A kreatinin m r se a vese betegs geinek diagn zis ban s kezel s ben v lhat sz ks gess illetve dial zis
48. iagnosticsBu Diamond Diagnostics The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 3 of 20 DIAMOND Creatine Reagent BA TE eee A Beckman Synchron CX amp CX Delta Analyzers BK 443340D Bulgarian 0 6 to 25 mg dl
49. icien Lors de la manipulation avec les solutions portez des vetements de protection appropri s et des gants pour viter tout risque de brulure Stockage et Stabilit L alcaline buffer et la solution picrigue restent stable jusqu la date de p remption indiqu e sur l tiquette du flacon Ne jamais utiliser apres cette date Le r actif combin reste stable pendant 30 jours si stock propre et a la temperature ambiante Stockez en position debout a temperature ambiante 18 25 C Ne pas congeler ou surgeler la solution ni le r actif Pr cipitation possible a basse temperature A 37 C le pr cipit se dissout Ne pas utiliser jusqu a ce que tout le pr cipite soit dissous Avant usage mixer dans le sens inverse Proc dure Proc dure Produit consid r comme l quivalent fonctionnel du mat riel pr existant distribu par Original Equipment Manufacturer OEM Ne pas pr parer le r actif a c est a faire juste avant d utilisation La solution doit etre pr par avant d installation a automate versez un flacon de Solution d acide picrique dans un flacon de r actif Alcaline buffer capsulez et mixez dans le sens inverse Pour les informations d taill es concernant l utilisation de ce r actif consultez le Manuel op ratoire Controle Qualit Diamond Diagnostics suggere d utiliser du mat riel de controle dont le r sultat a t d ja analys aux appareils utilis s Controle a faire au niveau normal et
50. ili fino alla data di scadenza elencata sulla bottiglia ll prodotto non dovrebbe essere usato dopo questa data Il reagente lavorativo combinato stabile per 30 giorni dal tempo di mischiato se conservato propriamente a temperatura ambiente Conservare a temperatura ambiente fra 18 25 C Non congelare o refrigerare la soluzione o il reagente lavorativo La precipitazione dovrebbe avvenire a temperatura bassa Il precipitato si dissolver quando sar riscaldato a 37 C Non usare finch tutto il precipitato non si dissolto Mischiare per capovolgimento prima dell uso Procedure Procedure Serve per sostituire i materiali gi esistenti distribuiti dai OEM Non preparare reagente lavorativo finch non pronto La soluzione lavorativa preparato con la priorit di installare sullo strumento cosi versare una bottiglia di Acido Picrico Soluzione nella bottiglia dell Alkaline Buffer Reagente tappare e mischiare con capovolgimento dolce Per una descrizione dettagliata di questo reagente leggere nella Manuale dell Utente Controllo di Qualit Diamond Diagnostics suggerisce l utilizzo di un materiale di controllo raggiungibile della quale i risultati sono stati gia anallizzati nel commercio controlli dovrebbero essere impiegati ai livelli Normali e Anormali Diamond Diagnostics suggerisce un controllo di misurazione prima di utilizzare i campioni e seguire la manutenzione dello strumento Limitazioni Serum Plasma o Urine sono
51. iser les deux R actifs Cr atinine Diamond et Beckman sur Synchron CX Delta Systeme Echantillons circuites pendant 20 jours 2 circuits jour 2 observations circuit Voir tableau 2 ci dessous 1 2 Range of Overall Mean within Total Matrix ee ad Reagent average Mean N mg dL run sd sd Diamond E LE Recovery Serum Control 1 80 1 6 0 07 0 14 Serum 9 04 0 20 mg dL Beckman 93421143 104 2 Serum Control 2 80 6 9 0 10 0 62 E E Diamond 87 1021 96 Urine Control 1 80 89 0 7 10 9 Uie BO E 962 Urine Control2 80 217 2 2 9 5 1 Jaffe M Z Physiological Chemistry 10 391 1886 2 Tietz N W ed Clinical Guide to Laboratory Tests 2 Edition W B Saunders Company Philadelphia 1994 3 Henry John Bernard Clinical Diagnosis and Management by Laboratory Methods 20 Edition W B Saunders Company Philadelphia 2001 4 SYNCHRON CX 3 Delta Clinical System Operating Instructions Beckman Instruments Inc Brea CA SYNCHRON CX 3 Clinical System Operating Instructions Beckman Instruments Inc Brea CA The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revisio
52. ition W B Saunders Company Philadelphia 1994 3 Henry John Bernard Clinical Diagnosis and Management by Laboratory Methods 20 Edition W B Saunders Company Philadelphia 2001 4 SYNCHRON CX 3 Delta Clinical System Operating Instructions Beckman Instruments Inc Brea CA SYNCHRON CX 3 Clinical System Operating Instructions Beckman Instruments Inc Brea CA The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 12 of 20 D 1 M O N D Creatine Reagenz Beckman Synchron CX 8 CX Delta Analyzers DIAGNOSTIC BK 443340D Italian Informazioni della Manufatturazione del Prodotto Diamond Diagnostics 333 Fiske Street Holliston MA Per un Aiuto Tecnico chiamare il numero seguente Diamond Diagnostics Technical Services at 1 508 429 0450 Uso previsto Creatinina Reagente per la determinazione per il quantitative della creatinina nel siero plasma o urine sul Beckman Synchron CX amp CX Delta Systems Somma dei Principi Fondamentali Questo prodotto serve per funzionare equivalentemente come materiali gi distribuiti dale Ditte OEM Importanza Clinica La misurazione della Creatinina usata nella diagnosi e trattamen
53. l Guide to Laboratory Tests 2 Edition W B Saunders Company Philadelphia 1994 3 Henry John Bernard Clinical Diagnosis and Management by Laboratory Methods 20 Edition W B Saunders Company Philadelphia 2001 4 SYNCHRON CX 3 Delta Clinical System Operating Instructions Beckman Instruments Inc Brea CA SYNCHRON CX 3 Clinical System Operating Instructions Beckman Instruments Inc Brea CA The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 18 of 20 D 1 M O N D Reactivo de Creatina Analizadores Beckman Synchron CX 8 CX Delta AA BK 443340D Spanish _Informaci n del Producto y del Fabricante Diamond Diagnostics 333 Fiske Street Holliston MA Para obtener asistencia tecnica por favor llamar al n mero telef nico 1 508 429 0450 Uso intencionado El reactivo de Creatina es usado en los Sistemas Beckman Synchron CX amp CX Delta para determinar cuantitativamente la Creatinina en el suero plasma u orina Resumen y Principio Este producto tiene como objectivo servir como equivalente al material distribuido por el Fabricante Original OEM Importancia Clinica Las medidas de Creatinina son usa
54. llow the procedures delineated within the Operator s Manual listed under Troubleshooting Ensure that all appropriate Maintenance Procedures as listed in the Operator s Manual have been performed If problems still exist contact Diamond Diagnostics Technical Service Department The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 1 of 20 DIAMOND Creatine Reagent Beckman Synchron CX amp CX Delta Analyzers BK 443340D Useable Range Creatine was found to have the following useable range 0 6 to 25 mg dL for Serum or Plasma 10 to 400 mg dL in Urine Samples with concentrations exceeding the high end of the useable range should be diluted with deionized water or saline and reanalyzed DIAGN OS Tic B Functional sensitivity Evaluated on dilutions of serum samples made from a starting serum of an approximately concentration of 0 9 mg dL dilutions were 1 3 1 5 1 11 and a O mg dL Samples were tested as 4 samples per run over 5 calibrated runs The lowest level where a CV of less than 20 was achieved was with the dilution at an expected value of 0 9 mg dL BUN which recovered as 0 6 mg dL with Diamond reagent 0 8 mg dL with Beckman reagent
55. n 07 Effective Date 07 12 17 Page 8 of 20 D i A M O N D Creatine Reagenz Beckman Synchron CX amp CX Delta Analyzers A iale BK 443340D German Hersteller und Produkt Information Diamond Diagnostics 333 Fiske Street Holliston MA Um die Technische Hilfe zu bitten rufen Sie die folgende Telefonnummer Diamond Diagnostics Technischer Kundendienst 1 508 429 0450 Verwendungszweck Creatine Reagenz dient der quantitativen Bestimmung von Kreatinin in Serium Plasma oder Urin auf den Beckman Synchron CX amp CX Delta Systemen Zusammenfassung und Grundsatz Dieses Produkt soll funktionales guvalent sein mit dem vorratigem Material was von dem Hersteller umgesetzt wird Klinische Bedeutung Kreatinen Messungen sind in der Diagnose und Behandlung von Nierenkrankungen eingesetzt in der Dialyse und als Berechnungsgrundlage fir die Messung anderer Urin Analyten Methodik Kreatinin indem man eine Probe mit dem alkalischen Pikrins ure Reagenz bestimmt Kreatinin aus der Probe kombiniert mit dem Reagenz zu einem roten Komplex zu erzeugen Kreatinin Picric Acid Kreatinin Picrate Komplex rot Absorptionswerte sind an beiden 520nm und 560nm bei 25 6 Sekunden nach Zugabe der Probe entnommen Die differentielle Absorption ist ein direktes Mass fiir die Konzentration von Kreatinin in der Probe Reagentien Kreatinin Reagenz Sett BK 443340D Enth lt Alkaline Buffer 3 x 1600mL enth lt w ssrige L sung 0 188 mol L NaOH
56. n DI 113 Le Kontroln mo 2 80 217 22 9 5 E iamon 102 vog 400 10 F Beckman 83 1029 96 2 1 Jaffe M Z Physiological Chemistry 10 391 1886 2 Tietz N W ed Clinical Guide to Laboratory Tests 2 Edition W B Saunders Company Philadelphia 1994 3 Henry John Bernard Clinical Diagnosis and Management by Laboratory Methods 20 Edition W B Saunders Company Philadelphia 2001 4 SYNCHRON CX 3 Delta Clinical System Operating Instructions Beckman Instruments Inc Brea CA SYNCHRON CX 3 Clinical System Operating Instructions Beckman Instruments Inc Brea CA The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 6 of 20 DIAMOND R actif Cr atine Beckman Synchron CXO amp CX Delta Analyseurs BK 443340D French Information Produit et Fabricant Diamond Diagnostics 333 Fiske Street Holliston MA Pour plus de renseignements contactez Diamond Diagnostics Support Technique 1 508 429 0450 OA E N DE F Conseil d utilisation Le r actif Cr atine est pr vu pour la quantification in vitro de la cr atinine dans le serum le plasma ou l urine humains pour Beckman Synchr
57. o diagnostic apenas uso Cauteloso Executar as precau es normais de laborat rio Se ocorrer contacto com a pele lave a rea afetada com gua Se ocorrer contacto com os olhos lave imediatamente com abund ncia de gua limpa ou banhos oculares Em casos de ingest o acidental procure um m dico imediatamente Estabilidade e Armazenamento O buffer de solu o alcalina e p crico s o est veis at a data de validade indicados no frasco O produto n o deve ser usado ap s esta data O reagente combinado de trabalho est vel durante 30 dias a partir do momento da mistura se armazenado adequadamente em temperatura ambiente Guardar na posi o vertical em temperatura ambient 18 25 C N o congelar ou refrigerar a solu o ou reagente de trabalho Precipita o pode ocorrer em temperaturas baixas O precipitado dissolve quando aquecido em 37 C N o use at que todos o precipitado se dissolva Misture por invers o antes do uso Procedimento Procedimento O produto fabricado em uma vers o pronta a usar destinado a servir como um substituto direto para materiais pr existentes distribu dos pela OEM N o preparar o reagente de trabalho at que esteja pronto para uso A solu o de trabalho preparado antes da instala o do instrumento por derramando uma garrafa de solu o de cido p crico em uma garrafa do Tamp o Alcalino Reagente misturando por invers o gentle Para uma descri o detalhada do uso deste
58. on CX amp CX Delta Systems R sum et Principe Ce produit est consid r comme l quivalent fonctionnel du mat riel pr existant distribu par Original Equipment Manufacturer OEM Signification clinique Les mesures de la cr atinine sont utilis es pour le diagnostique et le traitement de la n phropathie pour le controle de la dialyse r nale et comme base de calcul pour op rer d autres analyses d urine Methodologie Au cours de la r action la creatinine se combine avec le picrate en une solution alcaline pour former un complexe cr atinine picrate Creatinine Acide picrique Cr atinine Picrate Complex rouge La mesure de l absorbance de l chantillon est faite a 520 nm et 560 nm a 25 6 secondes a compter de la r action Cette variation d absorbance est directement proportionnelle a la concentration de cr atine dans l chantillon R actifs Kit de r actif cr atine BK 443340D Composants Alcaline buffer 3 x 1600mL est une solution aqueuse contenant 0 188 mol L NaOH Buffers tamponnes avec sodium borate et sodium phosphate surfactant et conservateur Solution d acide picrique 3 x 400 mL contenant 0 05 M acide picrique Uniquement pour diagnostique in vitro Avertissements Pr cautions normales exerc es aux laboratoires Si contact direct avec la peau rincez la surface affect e a l eau Si contact avec les yeux rincez imm diatement a l eau claire En cas d ingestion consultez imm diatement un phys
59. purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 20 of 20
60. reagente consulte o Manual do Operador do instrumento Controle de Qualidade Diamond Diagnostics sugere o uso de material de controlo comercialmente dispon veis com resultados analisados pelo instrumento utilizado Controlos devem ser analisados em n veis normais e anormais Diamond Diagnostics sugere medi o controles antes de amostras de pacientes s o executados e manuten o de aparelhos a seguir AAA Plasma soro ou urina s o a amostra de eleig o amostras de sangue total n o s o recomendados Anticoagulantes ou aditivos qu micos compat veis com este m todo s o Anticoagulantes N vel aceit vel Anticoagulantes N vel aceit vel Anticoagulantes N vel aceit vel Citrato de S dio 3 5 mg mL Heparin Am nio 45 Units mL Heparin S dio 45 Units mL EDTA 4 0 mg mL Heparin L tio 45 Units mL lodoacetate L tio 1 5 mg mL Esp cimes coletados em um tubo contendo citrato de s dio l quido ir apresentar uma diminuig o no valor para efeito de diluig o Amostras lip micas gt 3 devem ser ultracentrifugadas ea an lise realizada com o sobrenadante Consulte a bibliografia Literatura 2 e 3 de interfer ncias causadas por drogas e doen as Se o instrumento n o de calibra o e controles n o medem dentro da faixa aceit vel quando Diamond Diagnostics produtos s o utilizados Diamond Diagnostics sugere o seguinte Verifique se os calibradores internos usados para padronizar o instrumento s o correta para o instr
61. rocess de maintenance se passe selon les instructions du Manuel d Utilisation Si le probleme existe toujours contactez directement le Support Technique du Diamond Diagnostics The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 7 of 20 DIAMOND R actif Cr atine BA TE E A Beckman Synchron CX 8 CX Delta Analyseurs BK 443340D French Gamme a utiliser Creatine trouv a utiliser avec les unit s conventionnelles 0 6 25 mg dl pour Serum ou Plasma 10 400 mg dl dans Urine Les chantillons dont les concentrations d passent la limite sup rieure de lin arit doivent etre dilu s avec une solution saline et retest s Sensibilit fonctionnelle Calcul sur dilution de serum d chantillon se faisant d un serum initial d une concentration approximative de 0 9 mg dL dilutions taient 1 3 1 5 1 11 eta O mg dL Echantillons ont t test s selon les suivants 4 chantillons tourn e sur 5 tourn es calibrees Le niveau le plus bas pour une CV moins de 20 tait obtenu avec la dilution d une valeur attendue de 0 9 mg dL BUN r cup r e 0 6 mg dL avec Diamond r actif 0 8 mg dL avec Beckman r actif Intervalles r f rences
62. ske Street Holliston MA Para Assist ncia T cnica Ligue Diamond Diagnostics Assist ncia T cnica a 1 508 429 0450 DIAGN OS TIC amp S Pretendido Uso Reagente de Creatina para a determina o quantitativa de creatinina em plasma soro ou urina no Beckman Synchron CX amp CX Delta Sistemas Resumo e Princ pio Este produto destinado a servir como um equivalente funcional a materiais pr existentes distribu dos pelo Original Equipment Manufacturer OEM Significado Cl nico As determina es de creatinina s o utilizadas no diagn stico e tratamento de doen as renaisem di lise renal e como base de c lculo para medir outros analitos na urina Metodologia Creatinina determinada por uma mistura de amostra com o reagente alcalino p crico creatinine da amostra combina com o reagente para produzir um complexo de cor vermelha Creatinina cido Creatinina Picrato Complexo vermelha Leituras de absorb ncia s o tomadas em ambas as 520 nm e 560 nm em 25 6 segundos ap s a adi o da amostra A absorb ncia diferencial uma medida direta da concentra o de creatinina na amostra Reagentes Reagente Kit de Creatina BK 443340D que Cont m Tamp o Alcalino 3 x 1600mL uma solu o aquosa contendo 0 188 mol L NaOH Buffers buffered com borato de s dio e fosfato de s dio surfactante e conservante Solu o de cido p crico 3 x 400 mL contendo 0 05 M cido p crico Para in vitr
63. sor n valamint egy b vizeletmint k elemz sekor felmer l kalkul ci kban M dszertan A kreatinin meghat roz sa gy t rt nik hogy a minta pikrinsavval keveredik ekkor a mint b l sz rmaz kreatinin reakci ba l p a reagenssel s egy piros sz n kever ket kapunk Kreatinin Pikrinsav Kreatinin pikr t kever k piros sz n Az abszorpci s rt ket a minta hozz ad sa ut n 25 6 m sodperccel kell leolvasni 520 nm n l illetve 560 nm n l Az abszorpci s k l nbs gb l k zvetlen l m rhet a mint ban tal lhat kreatinin koncentr ci Reagensek Kreatin Reagens K szlet BK 443340D Tartalom L gos Buffer 3 x 1600mL vizes oldat tartalma 0 188 mol L NaOH n trium bor t n trium foszf t fel letakt v anyag tart s t szer Pikrinsavas oldat 3 x 400 mL tartalma 0 05 M Pikrinsav Kiz r lag in vitro diagnosztikai haszn latra Figyelmeztet sek Tartsa be a normal laborat riumi el r sokat Ha b rre ker l bl tse le az rintett ter letet v zzel Ha szembe ker l azonnal bl tse ki b s ges tiszta v zzel vagy szem bl t folyad kkal V letlenszer lenyel s eset n azonnal forduljon orvoshoz V d ruha s keszty haszn lata sz ks ges am g a pikrinsavas oldattal vagy annak kever k vel dolgozik mivel a pikrinsav a b rre s a ruh zatra n zve egyar nt mar hat s T rol s s Szavatoss g A savas buffer s a pikrin oldat szavatoss ga a palackon k
64. t k a k vetkez h g t si ar nyokkal 1 3 1 5 1 11 s m g egy O mg dL koncentr ci j minta is k sz lt A mint kat n gyes vel futtattuk tsz r egym s ut n minden ism tl sn l jabb kalibr ci val A legalacsonyabb szintet ami kevesebb mint 20 os vari ci egy tthat t CV jelent 0 9 mg dL BUN v rhat rt k h g t s val rt k el s ez a k vetkez ket mutatta 0 6 mg dL Diamond reagenssel 0 8 mg dL Beckman reagenssel Referenciatartomanyok A referenciatartom nyk nt megadott rt kek csak tmutat sk nt szolg lnak nem ir nyad rt kek Kort l nemt l s t pl lkoz st l f gg en lehetnek k l nbs gek amelyeket nem vett nk sz m t sba Minden laborat rium fel kell hogy ll tsa saj t referenciatartom nyait p ciensei sszet tele alapj n Mintat pus SI m rt kegys g Sz rum vagy Plazma 0 6 to 1 2 mg dL Vizelet id z tett 0 8 to 29 24 ra Teljes tm ny jellemz k A teljes tm nyre vonatkoz adatok CX 3 Delta s CXO9ALX k sz l kekr l sz rmaznak M dszerek sszehasonl t sa A Diamond kreatinin reagenst a Beckman reagenssel hasonl tottuk ssze Az oldott sz rum mint t h romszor futtattuk le s mindk t reagenssel is tesztelt k Diamond kreatinin reagens s a Beckman kreatinin reagens Az egyes megfigyel seket a legkisebb n gyzetek m dszer vel hasonl tottuk ssze s a k vetkez t ll tottuk fel Diamond 0 988 x Beckman 0 634 m
65. to delle malattie renali nelle dialisi renali e come calcolazione fondamentale per misurare altre analisi urinali Metodologia Creatinina determinata secondo un campione mescolato con il reagente alcalino picrico creatinina dal campione si combina con il reagente per produrre un complesso di colore rosso Creatinina Picrico Acido Creatinina Picrato Complesso rosso Le letture dell assorbanza sono prese sia a 520 nm e 560 nm al 25 6 secondi dopo i campioni aggiunti L assorbanza differente una misura diretta della concentrazione della creatinina nel campione Reagenti Creatinina Reagente Kit BK 443340D Contenuti Alkaline Buffer 3 x 1600mL una soluzione acquosa contiene 0 188 mol L NaOH Buffer tamponata con il borato di sodio e fosfato di sodio tensioattivo e conservante Picrico Acido Soluzione 3 x 400 mL contiene 0 05 M Picrico Acido Usare soltanto per in vitro diagnostica Cauzioni Esercitare le precauzioni normali da laboratorio Se contatta la pelle sciaquare la parte toccata con acqua Se contatta gli occhi sciaquare immediatamente con acqua pulita piu volte Nel caso di ingoiare casualmente occorre andare immediatamente dal medico Abbigliamento protettivo e guanti dovrebbero essere portati mentre si gestisce la soluzione picrica e la soluzione lavorativa siccome l acido picrico potrebbe macchiare sia la pelle che i vestiti Conservazione e Stabilit II tampone alcalino e la soluzione picrica sono stab
66. umento t m validade adequada e n o cont m contamina o visualmente evidente Siga os procedimentos delineados no Manual do Operador listados em Resolu o de Problemas Garantir que todos os procedimentos de manuten o adequada conforme listado no Manual do Operador foram realizados Se o problema persistir entre em contato Diamond Diagnostics Assist ncia T cnica The names of various manufacturers their instruments and their products referred to herein may be protected by trademark or other law and are used herein solely for purpose of reference Diamond Diagnostics expressly disclaims any affiliation with them or sponsorship by them ECO 8554 SOP05 1059F Revision 07 Effective Date 07 12 17 Page 15 of 20 DIAMOND Reagente de Creatina SA T IM eer ECE Beckman Synchron CX amp CX Delta Analisadores BK 443340D Portuguese nn Faixa Utiliz vel Creatina foi encontrado para ter o seguinte varia o utiliz vel 0 6 to 25 mg dL para soro ou plasma 10 to 400 mg dL in Urina As amostras cujas concentra es excedam o limite superior da faixa utiliz vel deve ser dilu do com gua deionizada ou solu o salina e novamente analisadas Sensibilidade Funcional Avaliados em dilui es de amostras de soro feito a partir de um soro de partida de uma concentra o de aproximadamente 0 9 mg dL dilui es foram 1 3 1 5 1 11 e um O mg dL Amostras foram testadas como 4 amostras por executar mais de 5 corre calibr
67. x100 foi calculado para ambos Diamond e Beckman Diamond e Beckman exibiu recupera es similares em toda a gama de valores em todas as matrizes Ver tabela 1 abaixo Precis o Soros de controlo comercialmente dispon veis e os controlos de urina foram analisadas usando tanto Diamond e Beckman Reagentes de Creatinina em Synchron CX Delta Sistema As amostras foram executados por 20 dias 2 processamentos por dia 2 observa es por ensaio Ver tabela 2 abaixo 1 2 Varia o de DE DE M dia 1 Gane Varia o de M dia Geral N Geral intra sd Total Matrix Eee Reagente Recupera o de dL sd p JdL Media Recupera o mg mg Soro Control 1 80 1 6 0 07 0 14 Se 934 1143 ns Soro Control 2 80 69 0 10 0 62 400 10 Damen 8721021 96 Urina Control 1 80 89 0 7 10 9 Urina mg dL Beckman 83 102 9 96 2 Urina Control 2 80 217 2 2 9 5 Refer ncias Literatura 1 Jaffe M Z Physiological Chemistry 10 391 1886 2 Tietz N W ed Clinical Guide to Laboratory Tests 2 Edition W B Saunders Company Philadelphia 1994 3 Henry John Bernard Clinical Diagnosis and Management by Laboratory Methods 20 Edition W B Saunders Company Philadelphia 2001 4 SYNCHRON CX 3 Delta Clinical System Operating Instructions Beckman Instruments Inc Brea CA SYNCHRON CX 3 Clinical System Operating Instructions Beckman Instruments In

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Creatine Reagent Kit Beckman Synchron CX® & CX® Delta